Fixation Instruments

FDA 510(k) K863727 · Medical Technology Development Corp.

Substantially Equivalent

510(k) numberK863727

Submission

Device name
Fixation Instruments
Applicant
Medical Technology Development Corp.
Clearwater, FL, US
Received
September 23, 1986
Decision date
October 31, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HNR – Forceps, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Specialty
Ophthalmic

Other 510(k)s with product code HNR

510(k)DeviceApplicantDecision
K022835Stephens Disposable ForcepsHNR · Traditional Stephens Instruments11/01/2002SE
K895434Alcon Folding ForcepsHNR · Traditional Alcon Laboratories12/04/1989SE
K891487Soft Lens Folding BlockHNR · Traditional Western Medical Products, Inc.08/15/1989SE
K893199Phaco-Injector(Tm) Intraocular Lens Implant InstrHNR · Traditional Allergan Medical Optics06/16/1989SE
K885230Mcdonald Folding ForcepsHNR · Traditional Alcon Laboratories05/17/1989SE
K881049Bradbury Intraocular Retinal Kit Cat #200HNR · Traditional Microline Pentax, Inc.09/12/1988SE
K883197Iol Implantation ForcepsHNR · Traditional D & D Surgical08/22/1988SE
K880274Advanced Surgical Products Scleral Plug ForcepsHNR · Traditional Advanced Surgical Products, Inc.02/05/1988SE
K864266Ophthalmic Knife & ForcepsHNR · Traditional Western Medical Products, Inc.11/28/1986SE
K864183Ophthalmic Surgical InstrumentsHNR · Traditional Techno Ophthalmics Intl.11/28/1986SE

More from Techno Ophthalmics Intl.

510(k)DeviceDecision
K941488Devmed Double-Balloon Urological CatheterEZL · Traditional 11/30/1994SE
K862315Fyodorov Collagen Corneal ShieldMOE · Traditional 01/07/1987SE
K863725Cataract Diamond KnifeHNN · Traditional 10/31/1986SE
K863726Instrument Sterilization TrayFSM · Traditional 10/14/1986SE

Questions and answers

When was Fixation Instruments cleared by the FDA?

Fixation Instruments (K863727) received a 510(k) decision of Substantially Equivalent on October 31, 1986, 38 days after the submission was received.

What is the product code of K863727?

The FDA product code is HNR – Forceps, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.